Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00539526
First received: October 2, 2007
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: Bimatoprost 0.03%
Drug: travoprost 0.004%
Drug: latanoprost 0.005% eye drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.


Secondary Outcome Measures:
  • Change From Baseline in Corneal Staining With Fluorescein at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.

  • Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.


Enrollment: 106
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
bimatoprost 0.03%
Drug: Bimatoprost 0.03%
bimatoprost 0.03%, 1 drop nightly for 3 months
Other Name: Lumigan®
Active Comparator: 2
travoprost 0.004%
Drug: travoprost 0.004%
travoprost 0.004% eye drops, 1 drop nightly for 3 months
Other Name: Travatan® Z
Active Comparator: 3
latanoprost 0.005%
Drug: latanoprost 0.005% eye drops
latanoprost 0.005%, 1 drop nightly for 3 months
Other Name: Xalatan®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

  • Known contraindication to latanoprost, bimatoprost or travoprost
  • Uncontrolled systemic disease
  • Active ocular disease other than glaucoma or ocular hypertension
  • Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539526

Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00539526     History of Changes
Other Study ID Numbers: MA-LUM-07-003
Study First Received: October 2, 2007
Results First Received: September 22, 2011
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Glaucoma
Eye Diseases
Latanoprost
Bimatoprost
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014